Project Manager - Engineering

Title: Project Director - Engineering

Status: Full-time, Exempt

Reports to:

Description

VahatiCor, a T45 Labs portfolio company, is seeking an Engineering Project Manager with expertise in Mechanical/ Biomedical Engineering to manage product development and manufacturing for Class II & Class III medical devices. This role will focus on project management of timelines, engineering requirements, product specifications, risk analysis, test protocols and reports. The ideal candidate has experience managing catheter products.

Responsibilities

• Manage project schedule
• Manage contract engineering catheter development project
• Manage team meetings
• Responsible for R&D within the organization and working closely with Quality, Regulatory, Clinical and Manufacturing teams

Documentation and Risk Management

Develop and maintain Manufacturing Process Instructions (MPIs), work instructions, test method, protocols for DV testing, and test report

Conduct risk assessments, including FMEA and hazard analysis (ISO 14971)

Work with R&D engineers, regulatory, quality, clinical and manufacturing teams to ensure the product meets all quality and regulatory requirements.

Qualifications

• Bachelor’s degree in Mechanical Engineering, BioMedical Engineering, or pure science field
• 5+ years of experience in Medical Device Research & Development engineering
• Hands-on experience with catheter processes
• Experience with SolidWorks
• Strong knowledge of ISO 13485, FDA regulations, and risk management (ISO 14971)
• Worked with inspection equipment and tensile testing equipment.

Location and Compensation

This is an on-site position, based in our Santa Clara, CA office.

T45 Labs is committed to fair and equitable pay practices, and compensation may include bonuses, equity, and benefits as part of the total rewards package.

The anticipated salary range of this position is $136,000 - $194,000 annually, based on San Francisco Bay Area market data. Actual compensation will vary depending on factors such as years of experience and skills.

Equal Employment Opportunity Statement

T45 Labs and its affiliated companies are Equal Opportunity Employers. We celebrate diversity and are committed to creating an inclusive environment for all employees. Employment decisions are based on qualifications, merit, and business needs.

We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other legally protected status.